After the Food and Drug Administration initially declined to review Moderna's mRNA flu vaccine candidate, the drugmaker said Wednesday that the FDA reversed its decision and will allow Moderna to move forward.
Moderna is seeking approval to administer the vaccine to adults ages 50-64. Moderna is also asking the FDA for an accelerated review for adults over age 65. If approved, the vaccine would be available for the 2026-27 flu season.
"We appreciate the FDA's engagement in a constructive Type A meeting and its agreement to advance our application for review," said Stéphane Bancel, CEO of Moderna. "Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu."
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Last week, Moderna got a letter from Center for Biologics Evaluation and Research Director Vinayak Prasad explaining that officials did not believe Moderna provided data from an "adequate and well-controlled" trial.
Moderna responded by saying the vaccine had been accepted for review in other nations, including the European Union and Canada.
Moderna has said that the mRNA vaccine has the potential to more precisely match circulating strains of the flu. Officials and vaccine makers have to decide months in advance on a strain to target for that season's flu vaccine. The company said that using mRNA technology can "support rapid response in a future influenza pandemic."
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According to Centers for Disease Control and Prevention statistics, 41.9% of adults in the U.S. got a flu vaccine, which is down from 44.9% the year before. The CDC says, "An annual flu vaccine is the best way to reduce the risk of illness and serious complications from flu."
